The University of Manchester

Steve RobertsAlexander HeazellElizabeth CamachoRoberto CarrascoKate Widdows

NHS EnglandNHS England

No

6357-D1D9-7BC8-3D2E-B28A-65C4

In 2020, 4,357 babies were stillborn or died shortly after birth. While the number of babies dying in the UK has steadily declined over the last decade, there is a national focus to prevent these deaths from occurring which is a key target in the NHS Long term Plan. Current research shows that a large proportion of deaths are potentially avoidable if improvements were made in at least one aspect of women’s antenatal care. To address this, in 2016 NHS England released a new set of guidelines for maternity providers called the Saving Babies Lives Care Bundle (SBLCB), specifically designed to reduce stillbirths and neonatal deaths. It aimed to improve the quality of care in four elements: reducing smoking in pregnancy, improving detection of small for gestational age babies, increasing maternal awareness of reduced fetal movements, and improving monitoring of babies’ heartbeat during labour. In 2018, a second version of the care bundle (SBLCBv2) was released which included a fifth element aimed at reducing preterm birth, as almost 70% of stillbirths in 2020 were born preterm before 37 weeks of pregnancy. This study will evaluate if SBLCBv2 is effective at reducing stillbirths, neonatal deaths and preterm births, and any unintended consequences, across all NHS maternity providers in England. It will assess how providers are using the SBLCBv2, compare clinical outcomes before and after the SBLCBv2, and assess how variation in implementation levels affects outcomes.

The death of a baby has significant psychological, social and economic consequences for parents and their families which persist for many years. Prevention of stillbirth and neonatal deaths remains a significant challenge for maternity services and is a key initiative the NHS Long Term plan. This study will evaluate whether implementation of NHS England's Saving Babies Lives Care Bundle Version 2 (SBLCBv2) in England reduces stillbirth and adverse neonatal outcomes. We are requesting data from NNRD to determine whether there is an association between the degree of implementation of SBLCBv2 and neonatal outcomes, including deaths during neonatal care and hypoxic-ischaemic encephalopathy. This specically relates to Aims 1, 3 & 4 of the study (section 3). This will provide evidence to advance knowledge about the processes that underpin successful implementation of SBLCBv2 as a whole and the individual elements, as well as unitended consequences, so that it can be further developed and refined. This has the potential to translate into substantial improvements in the rate of stillbirths, preterm births and adverse neonatal outcomes should SBLCBv2 be proved clinically effective. This study will only use aggregated anonymous data. Data from the NNRD will be at the Trust level; Trusts will not be identified in our reports. Therefore, we do not anticipate any risk to individual patient privacy or harm resulting from the use of the data.

30/01/2023

(a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes;

Not applicable

Not applicable

One-off

Release

Individual Trusts will not be identified in the report. During the study, press releases regarding the study may be disseminated. All press releases will need prior authorisation from the sponsor and NHS England. No third party will be permitted to submit publicity material without prior approval from the study team and NHS England. All conference presentations and abstracts relating to the study must be approved by NHS England prior to submission to the event organiser or editors.